VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM— 510(k) K061155

Substantially Equivalent

Zimmer Trabecular

FDA 510(k) clearance K061155 for VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM, Substantially Equivalent on 2006-09-22. Applicant: Zimmer Trabecular.

Clearance details

Applicant: Zimmer Trabecular
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2006-04-26
Decision date: 2006-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.